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Model Number 41-1010
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative

Explant witness marks are consistent with application of expected torque levels; associated instrumentation was noted to be within established specifications. Additional marks are consistent with progressive loosening. The last thread of one set screw exhibited damage consistent with forceful separation; the corresponding thread form of the mating component did not exhibit analogous damage. Review of the surgical events indicates appropriate technique with the exception of final tightening re-assessment following spinal alignment procedures as is a general practice recommended by deformity surgeons. Review of labeling: possible adverse events. Like other spinal system implants, the following adverse events are possible. This list is not exhaustive: delayed union or nonunion (pseudarthrosis) bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin. Dural leak requiring surgical repair. Cessation of growth of the fused portion of the spine. Subsidence of the implant into adjacent bone. Loss of proper spinal curvature, correction, height and/or reduction. Increased biomechanical stress on adjacent levels. Improper surgical placement of the implant causing stress shielding of the graft or fusion mass. Intraoperative fracture, or perforation of the spine. Postoperative fracture due to trauma, defects, or poor bone stock. Serious complications associated with any surgery may occur. These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death. Warnings and precautions. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery. The safety and effectiveness of spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the spine secondary to severe spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other condition is unknown. The implantation of this system should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. Which may impact the performance of the system. Ensure all implants, components or instruments are sterilized prior surgery. The use of non-sterile devices may lead to inflammation, infection or disease. Implants should never be reused under any circumstances. A used implant should be discarded. While the implant may appear undamaged, it may have small defects or internal stress patterns and if implanted, could fail to perform as intended and pose safety risks to the patient. The risks include, but are not limited to, mechanical failure, breakage, difficulty with implantation, incompatibility with mating components and infection. (b)(4).

Event Description

The patient underwent spinal surgery on (b)(6) 2020, which consisted of seaspine's mariner pedicle screw system. Seaspine was made aware on (b)(6) 2020 of qty (3) set screws that disassociated at s1-s2 and (2) additional that were loosened at s1 and l5. The patient was revised on (b)(6) 2020. Three set screws were replaced, and the surgeon rechecked and tightened the remaining set screws in the construct as needed.

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Type of DeviceSET SCREW
Manufacturer (Section D)
5770 armada drive
carlsbad, ca
Manufacturer (Section G)
5770 armada drive
carlsbad, ca
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, ca 
MDR Report Key10439951
MDR Text Key207527059
Report Number3012120772-2020-00064
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device MODEL Number41-1010
Device Catalogue Number41-1010
Device LOT NumberAW118251D
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/22/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 08/21/2020 Patient Sequence Number: 1